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The Cepheid Xpert®Respiratory Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A performed with the Cepheid Xpert® Xpress Flu/RSV assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A as the positive control and Coxsackie virus B1 as the negative control. The Cepheid Xpert®Respiratory Control Panel is not intended to replace manufacturer controls provided with the device.

The Cepheid Xpert® Respiratory Control Panel is used to monitor RNA extraction, amplification of the Cepheid Xpert® Xpress Flu/RSV assay. The Cepheid Xpert® Respiratory Control Panel contains cultured viruses inactivated by chemical or radiological treatments. Each Cepheid Xpert® Respiratory Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory syncytial virus A. Each negative control swab contains Coxsackie B1 virus. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The Cepheid Xpert® SA Nasal Complete Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicilin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) performed with the Cepheid Xpert® SA Nasal Complete Assay on the GeneXpert® Dx System. The controls comprise cultured and inactivated Methicillin-Resistant Staphylococcus aureus as the positive control 1: Staphylococcus aureus as the positive control 2; Staphylococcus epidermidis as the negative control. The Cepheid Xpert® SA Nasal Complete Control Panel is not intended to replace manufacturer controls provided with the Cepheid Xpert® SA Nasal Complete Assay.

The Cepheid Xpert® SA Nasal Complete Control Panel is used to monitor the DNA extraction, amplification and detection processes of the Cepheid Xpert® SA Nasal Complete Assay. The Cepheid Xpert® SA Nasal Complete Control Panel contains cultured microorqanisms inactivated by heat treatments. Each Cepheid Xpert® SA Nasal Complete Control Panel consists of 6 individually packaged Methicillin-Resistant Staphylococcus aureus (MRSA) positive control swabs (positive control 1): 6 individually wrapped Staphylococcus aureus (MSSA) positive controls swabs (positive control 2); and 6 individually wrapped negative control swabs. Each positive control 1 swab contains MRSA at a target level that is designed to provide reproducible performance above the limit of detection for each of the genes targeted by the Cepheid Xpert® SA Nasal Complete Assay: Staphylococcal protein A gene spa (SPA), methicillin resistance gene mecA (mec), and the Staphylococcal cassette chromosome (SCC). Each positive control 2 swab contains MSSA at a target level designed to provide reproducible performance above the limit of detection of the spa gene target of the Cepheid Xpert® SA Nasal Complete Assay. Each negative control swab contains Staphylococcus epidermidis (MSSE) which is methicillin susceptible and not detected by the Cepheid Xpert® SA Nasal Complete Assay. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The Cepheid Xpert® MRSA NxG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin-Resistant Staphylococus aureus performed with the Cepheid Xpert® MRSA NxG Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Methicillin-Resistant Staphylococcus aureus as the positive control and Staphylococcus epidermidis as the negative control. The Cepheid Xpert® MRSA NxG Control Panel is not intended to replace manufacturer controls provided with the Cepheid Xpert® MRSA NxG Assay.

The Cepheid Xpert® MRSA NxG Control Panel is used to monitor the DNA extraction, amplification and detection processes of the Cepheid Xpert® MRSA NxG Assay. The Cepheid Xpert® MRSA NxG Control Panel contains cultured microorganisms inactivated by heat treatments. Each Cepheid Xpert® MRSA NxG Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains cultured and inactivated Methicillin-Resistant Staphylococcus aureus (MRSA) at arget level that is designed to provide reproducible performance above the limit of detection for each of the genes targeted by the Cepheid Xpert® MRSA NxG Assay: methicillin resistance gene mecA (mec) and the Staphylococcal cassette chromosome (SCC). Each negative contains Staphylococcus epidermidis (MSSE) that is not detected by the Cepheid Xpert® MRSA NxG Assay. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The Cepheid Xpert® CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert® CT/NG assay on the GeneXpert® Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert® CT/NG Control Panel is not intended to replace manufacturer controls provided with the device.

The Cepheid Xpert® CT/NG Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® CT/NG Assay. The Cepheid Xpert® CT/NG Control Panel contains authentic pathogens inactivated by radiological or temperature treatments. Each Cepheid Xpert® CT/NG Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Chlamydia trachomatis and Neisseria gonorrhoeae as well as preservatives and stabilizers. Each negative control swab contains human cells as well as preservatives and stabilizers. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The Cepheid Xpert® C. difficile/Epi Control Panel is intended for use as external assayed positive and negative quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Clostridioides (Clostridium) difficile performed with the Cepheid Xpert® C. difficile/Epi assay on the GeneXpert® Dx System. The controls comprise cultured and inactivated Clostridioides (Clostridium) difficile 027-NAP1-B1 as the positive control and Clostridium sordellii as the negative control. The Cepheid Xpert® C. difficile/Epi Control Panel is not intended to replace manufacturer controls provided with the device.

The Cepheid Xpert® C. difficile/Epi Control Panel to monitor DNA extraction, amplification and detection of the Cepheid Xpert® C. difficile/Epi assay. The Cepheid Xpert® C. difficile/Epi Control Panel contains cultured microorqanisms inactivated by heat treatments. Each Cepheid Xpert® C. difficile/Epi Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains cultured and inactivated Clostridioides difficile at a target level that is designed to provide reproducible performance above the limit of detection of the Cepheid Xpert® C. difficile/Epi assay. The positive control swab is expected to produce positive results for each of the genes targeted by the Cepheid Xpert® C. difficile/Epi assay: toxin B (tcdB), binary toxin (CDT) and the variant requlator gene, tcdC. Each negative control swab contains Clostridium sordelli. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The Cepheid Xpert® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert® GBS LB Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert® GBS LB Control Panel is not intended to replace manufacturer controls provided with the device.

The Cepheid Xpert® GBS LB Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® GBS LB Assay. The Cepheid Xpert® GBS LB Control Panel contains authentic pathogens inactivated by temperature treatments. Each Cepheid Xpert® GBS LB Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Streptococcus agalactiae (Lancefield's Group B) as well as preservatives and stabilizers. Each negative control swab contains Lactobacillus as well as preservatives and stabilizers. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The BD MAX™ CT/GC/TV 20-Day QC Panel is intended for use as an external assayed positive quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis with the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The controls comprise cultured and inactivated C. trachomatis, N. qonorrhoeae and T. vaqinalis. The BD MAX CT/GC/TV™ 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.

The BD MAX™ CT/GC/TV 20-Day QC Panel is used to monitor the extraction, amplification and detection of the BD MAX™ CT/GC/TV Assay. The BD MAX™ CT/GC/TV 20-Day QC Panel contains authentic pathogens inactivated by radiological and temperature treatments. Each BD MAX™ CT/GC/TV 20-Day QC Panel consists of 20 individually packaged positive control pellets in a heat-sealed foil pouch. Each individually packaged pellet consists of inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis pathogens as well as preservatives and stabilized pellet containing inactivated organism(s) is packaged in a 2.0ml labeled micro-centrifuge tube with a red screw cap.

The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica. The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day OC Panel are not intended to replace manufacturer controls provided with the device.

The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are used to monitor the extraction, amplification of the BD MAX™ Enteric Parasite Panel. Both panels contain individually packaged pellets consisting of inactivated, Cryptosporidium parvum, Giardia lamblia, and a recombinant Escherichia coli. The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel differ only by packaged quantity. Each BD MAX™ Enteric Parasite Control Panel consists of 6 individually packaged positive control pellets. Each BD MAX™ Enteric Parasite 20-Day QC Panel consists of 20 individually packaged positive control pellet is individually wrapped with a desiccant in a heat-sealed foil pouch. The organisms are prepared in a buffered solution with materials of animal origin, preservatives and stabilizers. The solution is lyophilized into a ready-to-use pellet containing inactivated orqanism(s) is packaged in a 2.0-ml labeled micro-centrifuge tube with a red screw cap. The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel do not contain negative controls.